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CTRI Number  CTRI/2021/12/038785 [Registered on: 21/12/2021] Trial Registered Prospectively
Last Modified On: 16/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Nurse-led intervention on weight reduction among adults with obesity in urban areas of Puducherry 
Scientific Title of Study   Effectiveness of nurse-led intervention on weight reduction among adults with obesity in urban areas of Puducherry–An exploratory sequential mixed method. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M J Kumari 
Designation  Professor 
Affiliation  JIPMER 
Address  College of Nursing, JIPMER
College of Nursing, JIPMER
Pondicherry
PONDICHERRY
605006
India 
Phone  9894595420  
Fax    
Email  kumari_mj@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M J Kumari 
Designation  Professor 
Affiliation  JIPMER 
Address  College of Nursing, JIPMER
College of Nursing, JIPMER
Pondicherry
PONDICHERRY
605006
India 
Phone  9894595420  
Fax    
Email  kumari_mj@ymail.com  
 
Details of Contact Person
Public Query
 
Name  VEMBUK 
Designation  TUTOR 
Affiliation  JIPMER 
Address  College of Nursing, JIPMER
College of Nursing, JIPMER
Pondicherry
PONDICHERRY
605006
India 
Phone  7845506589  
Fax    
Email  vkjipmer11@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education And Research- Intra mural Research Fund 
 
Primary Sponsor  
Name  JIPMER Intra Mural Research Fund 
Address  JIPMER,Gorimedu,Puducherry 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M J Kumari  Urban areas of Puducherry.  Mudaliarpet, Odiansalai, Kosapalayam, Murungapakkam Muthialpet, Dubrayapet, Lawspet, Reddiarpalayam , Mettupalayam , Gorimedu, Villianur, Ariankuppam.
Pondicherry
PONDICHERRY 
9894595420

kumari_mj@ymail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR NURSING COURSE RESEARCH, JIPMER, PUDUCHERRY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E660||Obesity due to excess calories,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GENERAL CARE SERVICES   Comparator group will receive the general care services provided by URBAN PRIMARY HEATLH CENTRE 
Intervention  NURSE-LED INTERVENTION ON WEIGHT REDUCTION  I. Health education (at common area) The study participants will be explained on causes of obesity, day to day problems related to obesity, serious health conditions caused by obesity for 15 minutes using pictures on PPT. The study participants will be explained on low carb diet, protein rich diet, low fat diet and fiber rich diet and food to include and avoid by pictures using PPT for 30 minutes. The study participants will be given millet based model menu with 6 breakfasts, 6 lunches, and 6 dinners with adequate vegetables, fruits, protein which fulfils their calorie needs to follow in their day to day life. Model menu plan (individually tailored) will be prepared based on calorie requirement with 10-15% of calorie deficit, physical activity and spending ability on food.The study participants will be explained on walking and home work outs. II. Motivational strategy during follow up Participants are asked to maintain food diary and activity diary by own. Calorie intake will be calculated using Diet Cal software and participant will be contacted via mobile to inform about their track. Participants will be interacting with an investigator through phone calls, sms or text messages regarding adherence to intervention, information on weight reduction, clarification of doubts and interact with study participants monthly once. Separate register will be maintained for phone calls. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Adults with obesity, aged between 18-50 yrs, all gender,who can speak and write Tamil or English,who access to phone.
 
 
ExclusionCriteria 
Details  Adults with limitations for physical activities (physical disability and bed ridden), with medications and diseases, which can affect weight loss, currently on weight loss program, bariatric surgery and pregnant, visual and hearing impairments.
• Psychiatric disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinically significant reduction in body weight ≥ 5% from baseline weight among intervention group compared with general care group.  Baseline assessment- at 1st month
Midline assessment-at 6th month
Endline assessment-at 12th month 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of beneficial effect among nurse-led intervention group
1. Reduction in absolute weight.
2. Reduction in waist circumference.
3. Beneficial changes in FBS, lipid profile.
4. Positive changes on lifestyle (diet, physical activity) modification
 
One year 
 
Target Sample Size   Total Sample Size="438"
Sample Size from India="438" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="438" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2022 
Date of Study Completion (India) 29/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
1. Krishnasamy V, Jayaram KM, Jayaseelan V.Protocol of randomized controlled trial to evaluate the effectiveness of nurse‐led intervention on weight reduction among adults with obesity in urban areas of Puducherry. Indian J Endocr Metab 2023;27:154‐60-Indian Journal of Endocrinology and Metabolism 2. Krishnasamy V, Jayaram KM, Jayaseelan V.Fruit- Vegetables Intake And Physicalactivity On The Risk Of Metabolic Syndrome Among Obese Adults In Urban, Puducherry. International Journal Of Scientific Research (Ijsr), Vol. 13, Issue, 2. February 2024. 3.Krishnasamy, Vembu1; Jayaram, Kumari Manjini2; Jayaseelan, Venkatachalam3; Shanmugam, Ramesh4; Sadan, Vathsala5. Effectiveness of nurse-led intervention on weight reduction among adults in urban Puducherry – A randomized controlled pilot trial. Journal of Education and Health Promotion 13(1):210, June 2024. | DOI: 10.4103/jehp.jehp_1411_23  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
This is randomized trial to evaluate the effectiveness of  nurse-led intervention on weight reduction among adults with obesity in urban areas of Puducherry. 

Report of the Pilot Study:

The recent increase in type 2 diabetes is likely due to the rising prevalence of overweight and obesity, which heightens the risk of non-communicable diseases. This study aimed to evaluate the effectiveness of nurse-led intervention (NLI) strategies on weight reduction among adults in urban Puducherry. A two-arm, parallel-group, randomized controlled study was conducted with 88 obese adults from Nesavalar colony and Govindanpet between November 2022 and February 2023. Participants were randomized into either the NLI or general care (GC) arm. Interviews were conducted to gather demographic and behavioral risk factor data, and physical and biochemical measurements were taken following standardized procedures. Villages were randomly assigned to either the intervention or control group using Excel. The NLI group received nurse-led interventions, including Surya Namaskar yoga, while the GC group received standard care. At 16 weeks, the NLI arm showed a significant mean weight loss of -2.58 kg, compared to a 0.38 kg gain in the GC arm, with improvements in waist circumference, body mass index, cholesterol profile, and thyroid-stimulating hormone levels. The study demonstrated that nurse-led interventions effectively reduced weight and the risk of non-communicable diseases in urban Puducherry, though a more extensive follow-up plan and additional manpower will be necessary for larger studies. 

Summary of the Main Study:

Participants were interviewed to gather demographic information and assess behavioral risk factors, including diet and physical activity. Physical measurements such as height, weight, waist circumference, and blood pressure were taken following standardized procedures. Biochemical measurements involved blood sample collection after overnight fasting to analyze fasting blood glucose, total cholesterol, and thyroid profile. Villages were randomly assigned to either the intervention or control group using Excel, ensuring equal distribution. No allocation concealment was used since the intervention was applied simultaneously across villages, reducing selection bias. Blinding was not implemented due to the primary investigator’s involvement in both intervention delivery and baseline assessments; however, outcome assessments were conducted by independent nurses who were blinded to group assignments. The intervention group received nurse-led interventions, including sessions on Surya Namaskar (Sun Salutation) yoga, while the control group received standard care. After 12 months, participants’ weight reduction was reassessed and compared with baseline data, and health workers in the control group were subsequently educated using the nurse-led intervention package. COVID-19 precautions were implemented to prevent transmission, particularly in containment zones.

 
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